Interventional cardiologist Ali Massumi, MD was the first physician in the U.S. to replace a pacemaker enclosed in a mesh envelope. The envelope, made of standard surgical mesh, is embedded with two antibiotic agents that provide site-specific antibiotic protection for the pacemaker, which is implanted just below the collarbone. This prevents the need for systemic antibiotics (taken orally). The device is made by TyRx Pharma, Inc., which recently received FDA approval.

“Pacemakers are placed in an area where there aren’t a lot of blood vessels, so systemic antibiotics may not reach the specific area. Replacing leads which run from the pacemaker to the heart can be quite difficult because of scarring in the area. These high risk patients are more prone to infection and obviously we want to avoid any infection to the heart,” said Dr. Massumi.

The patient who received the new pacemaker was Mr. Genaro Nieto, 72, of Houston. Mr. Nieto received his first pacemaker about seven years ago. Mr. Nieto received the new pacemaker recently and was discharged from St. Luke’s Episcopal Hospital several hours later.

“The envelope provides antibiotic protection for about ten days after the procedure. It also helps to stabilize the device in the body. This device will also make it easier for future device replacement. Mr. Nieto had a large amount of scar tissue around his previous pacemaker, and we removed the scar tissue before implanting the new pacemaker,” said Dr. Massumi.

On average, pacemaker batteries need to be replaced every five to seven years, but the time span varies widely depending on the patient, the specific device and its energy needs. Nationally, about seven percent of high risk patients develop infections following the procedure.

“Personally, I’ve observed infections in about one or two percent of patients following this procedure. Obviously, we want to provide our patients with every advantage available to prevent this complication. This device looks quite promising to achieve that and to make future procedures easier,” said Dr. Massumi.